National Syphilis Serum Bank
Research type
Research Study
Full title
Establishment of a national syphilis serum bank
IRAS ID
146961
Contact name
Helen Fifer
Contact email
Sponsor organisation
UKHSA
Research summary
Syphilis presents in various ways, depending on the stage of infection (primary, secondary, early and late latent, and tertiary). It is caused by the bacteria Treponema pallidum, and infection is diagnosed by using a range of several different antibody tests. In 2011 there was an unexpected increase in positive results for one of these antibody tests, using three batches of a specific kit. An extensive investigation found a false positive rate of 75-95% and 75 patients received inappropriate treatment for syphilis. Any refinements to new or existing test kit quality assurance may prevent future recurrence of a similar scenario.
There is no national serum bank representative of the different stages of infection that could be used for test validation, verification and ongoing quality assurance. To create such a bank, centres from around England that have significant experience in diagnosing and managing all stages of syphilis will be selected. Each site will be asked to contribute serum samples from patients with each clinically defined disease stage (primary, secondary, early and late latent, and if seen, tertiary). In order to achieve sufficient sera volumes in the bank, an additional sample from each patient will be required, rather than using residual samples from initial diagnostic testing by the local laboratory. Relevant information will be recorded: rationale for clinical staging, appropriate comorbidities (such as HIV or other immunosuppression, as well as rheumatological and immunological conditions that may affect serological diagnostic testing).REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/1763
Date of REC Opinion
24 Sep 2014
REC opinion
Favourable Opinion